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Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 1 of 12 PageID: 97
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`
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`
`
`Andrew J. Miller
`Stuart D. Sender
`Alan H. Pollack
`Dmitry Shelhoff
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078
`Tel: (973) 379-4800
`
`Attorneys for Defendants
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
`
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`Defendants
`
`
`
`ANSWER OF DR. REDDY’S LABORATORIES, LTD.
`AND DR. REDDY’S LABORATORIES, INC.
`
`Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`
`(collectively “DRL”) by their attorneys, for their answer to the Complaint by AstraZeneca AB,
`
`AstraZeneca LP, and Pozen Inc., (collectively, “AstraZeneca” or “Plaintiffs”) respond to
`
`allegations as follows:
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`00917971
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`1
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`
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`Civil Action No. 3:13-cv-00091 (JAP)(TJB)
`
`ELECTRONICALLY FILED
`
`
`
`
`ASTRAZENECA AB, ASTRAZENECA LP,
`and POZEN INC.,
`
`
`Plaintiffs,
`
`v.
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 2 of 12 PageID: 98
`
`Nature of the Action
`
`1.
`
`DRL admits the allegations contained in paragraph 1 of the Complaint.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`
`The Parties
`
`DRL admits the allegations contained in paragraph 2 of the Complaint.
`
`DRL admits the allegations contained in paragraph 3 of the Complaint.
`
`DRL admits the allegations contained in paragraph 4 of the Complaint.
`
`DRL admits the allegations contained in paragraph 5 of the Complaint.
`
`DRL admits the allegations contained in paragraph 6 of the Complaint.
`
`DRL admits the allegations contained in paragraph 7 of the Complaint.
`
`DRL admits the allegations contained in paragraph 8 of the Complaint.
`
`BACKGROUND
`
`The NDA
`
`DRL admits the allegations contained in paragraph 9 of the Complaint.
`
`DRL admits the allegations contained in paragraph 10 of the Complaint.
`
`The Patent in Suit
`
`11.
`
`DRL denies the allegations of paragraph 11 of the Complaint, except admits that
`
`the U.S. Patent No. 6,926,907 (“the ‘907 patent”), entitled “Pharmaceutical Compositions for the
`
`Coordinated Delivery of NSAIDs,” issued on August 9, 2005, and that the Complaint annexes a
`
`copy of the ‘907 patent as Exhibit A.
`
`12.
`
`DRL lacks information or knowledge sufficient to admit or deny the allegations
`
`set forth in paragraph 12 of the Complaint, except that DRL admits that the ‘907 patent states on
`
`its face that the assignee of the patent is Pozen Inc.
`
`00917971
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`2
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`

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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 3 of 12 PageID: 99
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`13.
`
`DRL denies the allegations of paragraph 13 of the Complaint, except admits that
`
`the U.S. Patent No. 5,714,504 (“the ‘504 patent”), entitled “Compositions,” issued on February
`
`3, 1998, and that the Complaint annexes a copy of the ‘504 patent as Exhibit B.
`
`14.
`
`DRL lacks information or knowledge sufficient to admit or deny the allegations
`
`set forth in paragraph 14 of the Complaint, except that DRL admits that the ‘504 patent states on
`
`its face that the assignee of the patent is Astra Aktiebolag.
`
`15.
`
`DRL denies the allegations of paragraph 15 of the Complaint, except admits that
`
`the U.S. Patent No. 7,745,466 (“the ‘466 patent”), entitled “Form of S-omeprazole,” issued on
`
`June 29, 2010, and that the Complaint annexes a copy of the ‘466 patent as Exhibit C.
`
`16.
`
`DRL lacks information or knowledge sufficient to admit or deny the allegations
`
`set forth in paragraph 16 of the Complaint, except that DRL admits that the ‘466 patent states on
`
`its face that the assignee of the patent is AstraZeneca AB.
`
`17.
`
`DRL denies the allegations of paragraph 17 of the Complaint, except admits that
`
`the U.S. Patent No. 7,411,070 (“the ‘070 patent”), entitled “Form of S-omeprazole,” issued on
`
`August 12, 2008, and that the Complaint annexes a copy of the ‘070 patent as Exhibit D.
`
`18.
`
`DRL lacks information or knowledge sufficient to admit or deny the allegations
`
`set forth in paragraph 18 of the Complaint, except that DRL admits that the ‘070 patent states on
`
`its face that the assignee of the patent is AstraZeneca AB.
`
`19.
`
`DRL denies the allegations of paragraph 19 of the Complaint, except admits that
`
`the U.S. Patent No. 6,369,085 (“the ‘085 patent”), entitled “Form of S-omeprazole,” issued on
`
`April 9, 2002, and that the Complaint annexes a copy of the ‘085 patent as Exhibit E.
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`00917971
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`3
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 4 of 12 PageID: 100
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`20.
`
`DRL lacks information or knowledge sufficient to admit or deny the allegations
`
`set forth in paragraph 20 of the Complaint, except that DRL admits that the ‘085 patent states on
`
`its face that the assignee of the patent is AstraZeneca AB.
`
`The ANDA
`
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`DRL denies the allegations contained in paragraph 21 of the Complaint.
`
`DRL admits the allegations contained in paragraph 22 of the Complaint.
`
`JURISDICTION AND VENUE
`
`DRL admits the allegations contained in paragraph 23 of the Complaint.
`
`DRL admits the allegations contained in paragraph 24 of the Complaint.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 25 of the Complaint.
`
`26.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 26 of the Complaint.
`
`27.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 27 of the Complaint.
`
`28.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 28 of the Complaint.
`
`29.
`
`30.
`
`31.
`
`32.
`
`DRL admits the allegations contained in paragraph 29 of the Complaint.
`
`DRL admits the allegations contained in paragraph 30 of the Complaint.
`
`DRL admits the allegations contained in paragraph 31 of the Complaint.
`
`DRL admits jurisdiction and venue in this case, with the balance being legal
`
`points which require no response.
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`00917971
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`4
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`

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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 5 of 12 PageID: 101
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`33.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 33 of the Complaint.
`
`34.
`
`35.
`
`36.
`
`37.
`
`DRL admits the allegations in paragraph 34 of the Complaint.
`
`DRL admits the allegations in paragraph 35 of the Complaint.
`
`DRL admits the allegations in paragraph 36 of the Complaint.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 37 of the Complaint.
`
`38.
`
`DRL admits the allegations in paragraph 38 of the Complaint.
`
`COUNT I
`(INFRINGEMENT OF THE ‘907 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
`
`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
`
`39.
`
`forth here.
`
`40.
`
`DRL denies the allegations of paragraph 40 of the Complaint, except admits that
`
`it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
`
`41.
`
`DRL admits that it was aware of the text of the 21 U.S.C. § 355(j)(2) and 21
`
`C.F.R. § 314.95 (c) and denies the remaining allegations in paragraph 41 of the Complaint.
`
`42.
`
`43.
`
`44.
`
`45.
`
`46.
`
`DRL denies the allegations contained in paragraph 42 of the Complaint.
`
`DRL denies the allegations contained in paragraph 43 of the Complaint.
`
`DRL denies the allegations contained in paragraph 44 of the Complaint.
`
`DRL denies the allegations contained in paragraph 45 of the Complaint.
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`DRL denies the allegations contained in paragraph 46 of the Complaint.
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`
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`5
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`00917971
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 6 of 12 PageID: 102
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`COUNT II
`(INFRINGEMENT OF THE ‘504 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
`
`47.
`
`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
`
`
`
`forth here.
`
`48.
`
`DRL denies the allegations of paragraph 48 of the Complaint, except admits that
`
`it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
`
`49.
`
`DRL admits that it was aware of the text of the 21 U.S.C. § 355(j)(2) and 21
`
`C.F.R. § 314.95 (c) and denies the remaining allegations in paragraph 49 of the Complaint.
`
`50.
`
`DRL denies the allegations contained in paragraph 50 of the Complaint, except
`
`admits that its Notice of Paragraph IV Certification, dated November 20, 2012, does not allege
`
`non-infringement of claims 1-3, 5-7, and 10 of the ‘504 patent, based on the information
`
`available to DRL as of the time of the service.
`
`51.
`
`52.
`
`53.
`
`54.
`
`55.
`
`DRL denies the allegations contained in paragraph 51 of the Complaint.
`
`DRL denies the allegations contained in paragraph 52 of the Complaint.
`
`DRL denies the allegations contained in paragraph 53 of the Complaint.
`
`DRL denies the allegations contained in paragraph 54 of the Complaint.
`
`DRL denies the allegations contained in paragraph 55 of the Complaint.
`
`COUNT III
`(INFRINGEMENT OF THE ‘466 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
`
`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
`
`56.
`
`forth here.
`
`57.
`
`58.
`
`59.
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`00917971
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`
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`DRL denies the allegations contained in paragraph 57 of the Complaint.
`
`DRL denies the allegations contained in paragraph 58 of the Complaint.
`
`DRL denies the allegations contained in paragraph 59 of the Complaint.
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`6
`
`

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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 7 of 12 PageID: 103
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`60.
`
`61.
`
`DRL denies the allegations contained in paragraph 60 of the Complaint.
`
`DRL denies the allegations contained in paragraph 61 of the Complaint.
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`COUNT IV
`(INFRINGEMENT OF THE ‘070 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
`
`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
`
`62.
`
`forth here.
`
`63.
`
`DRL denies the allegations of paragraph 63 of the Complaint, except admits that
`
`it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
`
`64.
`
`DRL admits that it was aware of the text of the 21 U.S.C. § 355(j)(2) and 21
`
`C.F.R. § 314.95 (c) and denies the remaining allegations in paragraph 64 of the Complaint.
`
`65.
`
`DRL denies the allegations contained in paragraph 65 of the Complaint, except
`
`admits that its Notice of Paragraph IV Certification, dated November 20, 2012, does not allege
`
`invalidity of claims 2 and 4 of the ‘070 patent, based on the information available to DRL as of
`
`the time of the service.
`
`66.
`
`67.
`
`68.
`
`69.
`
`70.
`
`DRL denies the allegations contained in paragraph 66 of the Complaint.
`
`DRL denies the allegations contained in paragraph 67 of the Complaint.
`
`DRL denies the allegations contained in paragraph 68 of the Complaint.
`
`DRL denies the allegations contained in paragraph 69 of the Complaint.
`
`DRL denies the allegations contained in paragraph 70 of the Complaint.
`
`COUNT V
`(INFRINGEMENT OF THE ‘085 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
`
`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
`
`71.
`
`forth here.
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`00917971
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`7
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`

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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 8 of 12 PageID: 104
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`72.
`
`DRL denies the allegations of paragraph 72 of the Complaint, except admits that
`
`it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
`
`73.
`
`DRL admits that it was aware of the text of the 21 U.S.C. § 355(j)(2) and 21
`
`C.F.R. § 314.95 (c) and denies the remaining allegations in paragraph 73 of the Complaint.
`
`74.
`
`75.
`
`76.
`
`77.
`
`78.
`
`79.
`
`80.
`
`DRL admits the allegations contained in paragraph 74 of the Complaint.
`
`DRL denies the allegations contained in paragraph 75 of the Complaint.
`
`DRL denies the allegations contained in paragraph 76 of the Complaint.
`
`DRL denies the allegations contained in paragraph 77 of the Complaint.
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`DRL denies the allegations contained in paragraph 78 of the Complaint.
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`DRL denies the allegations contained in paragraph 79 of the Complaint.
`
`DRL denies the allegations contained in paragraph 80 of the Complaint.
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`PRAYER FOR RELIEF
`
`81.
`
`DRL denies that Plaintiffs are entitled to judgments and relief prayed for in
`
`paragraphs A through G of the Complaint.
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`AFFIRMATIVE DEFENSES
`
`82.
`
`DRL alleges and asserts the following affirmative defenses in response to the
`
`allegations in AstraZeneca’s Complaint:
`
`First Affirmative Defense
`(Non-infringement of Valid and Enforceable Claims)
`
`The manufacture, use, offer for sale, sale or importation of the product described
`
`83.
`
`in DRL’s ANDA 204206 does not and will not infringe (either literally or under the doctrine of
`
`equivalents), directly or indirectly (either by inducement or contributorily), any valid or
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`enforceable claim of the ‘907, ‘504, ‘466, ‘070 or ‘085 patents (collectively “patents-in- suit”).
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`
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`00917971
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 9 of 12 PageID: 105
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`Second Affirmative Defense
`(Invalidity)
`
`At least claims 1, 5, 9-17, 21-24, 28-29, 32-35, 37, 41-42, 45-48, and 50-55 of the
`
`84.
`
`‘907 patent are invalid under Title 35 United States Code, including, inter alia, §§101, 102, 103,
`
`112, and for double patenting.
`
`85.
`
`All claims of the ‘504 patent are invalid under Title 35 United States Code,
`
`including, inter alia, §§101, 102, 103, 112, and for double patenting.
`
`86.
`
`All claims of the ‘466 patent are invalid under Title 35 United States Code,
`
`including, inter alia, §§101, 102, 103, 112, and for double patenting.
`
`87.
`
`All claims of the ‘070 patent are invalid under Title 35 United States Code,
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`including, inter alia, §§101, 102, 103, 112, and for double patenting.
`
`88.
`
`All claims of the ‘085 patent are invalid under Title 35 United States Code,
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`including, inter alia, §§101, 102, 103, 112, and for double patenting.
`
`Third Affirmative Defense
`(Non-Infringement)
`
`The manufacture, use, sale, offer to sell in the United States or the importation
`
`89.
`
`into the United States of the product described in DRL’s ANDA 204206 does not and would not
`
`infringe any of the claims of the ‘907 patent.
`
`90.
`
`The manufacture, use, sale, offer to sell in the United States or the importation
`
`into the United States of the product described in DRL’s ANDA 204206 does not and would not
`
`infringe at least claims 4, 8, and 9 of the ‘504 patent.
`
`
`
`91.
`
`The manufacture, use, sale, offer to sell in the United States or the importation
`
`into the United States of the product described in DRL’s ANDA 204206 does not and would not
`
`infringe any claim of the ‘466 patent.
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`00917971
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 10 of 12 PageID: 106
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`92.
`
`The manufacture, use, sale, offer to sell in the United States or the importation
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`into the United States of the product described in DRL’s ANDA 204206 does not and would not
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`infringe any claim of the ‘070 patent.
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`93.
`
`The manufacture, use, sale, offer to sell in the United States or the importation
`
`into the United States of the product described in DRL’s ANDA 204206 does not and would not
`
`infringe any claim of the ‘085 patent.
`
`Fourth Affirmative Defense
`(Prosecution History Estoppel)
`
`94.
`
`Claims of the patents in suit are so limited as not to cover the manufacture, use,
`
`offer for sale, sale or importation of the product described in DRL’s ANDA 204206 due to the
`
`arguments, statements, representations and/or amendments made by Plaintiffs to the United
`
`States Patent and Trademark Office during the prosecution of the respective applications leading
`
`to issuance of each of the patents in suit.
`
`Fifth Affirmative Defense
`
`95.
`
`Each of Plaintiffs’ allegations of infringement of each of the patents in suit under
`
`271(a), (b), and/or (c) fails to state a claim upon which relief can be granted.
`
`WHEREFORE, DRL prays for relief as follows:
`
`PRAYER FOR RELIEF
`
`(a)
`
`(b)
`
`That the Complaint against DRL be dismissed in its entirety and with prejudice;
`
`That the Court permanently enjoin Plaintiffs from asserting any one or more of
`
`the ‘907, ‘504, ‘466, ‘070 and/or ‘085 patents against DRL or the purchasers of its Proposed
`
`Product;
`
`(c)
`
`That this case be deemed to be an exceptional case within the meaning of 35
`
`U.S.C. § 285;
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`00917971
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`10
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`

`
`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 11 of 12 PageID: 107
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`
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`That DDRL be awaarded its attorney fees annd costs and
`
`
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`
`
`
`
`
`(dd)
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`
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`(ee)
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`That tthe Court awward other annd further rellief as it deeems just and
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`
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`
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`expenses of f the suit, andd;
`
`
`
`proper.
`
`_____________________
`
`
`
`Andrew
`J. Miller
`
`Stuart DD. Sender
`Alan H.
`Pollack
`
`Dmitry SShelhoff
`
`
`BUDD LLARNER, PP.C.
`
`
`150 Johnn F. Kennedyy Parkway
`
`
`Short Hiills, New Jerrsey, 07078
`
`Tel: (9733) 379-4800
`
`
`
`
`Attorneyys for Defenddants
`
`
`
`
`
`Dr. Redddy’s Laborattories, Inc.
`
`Dr. Redddy’s Laborattories, Ltd. aand
`
`
`By:
`
`
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`
`
`
`
`DDated: Januaary 11, 2013
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`00917971
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 12 of 12 PageID: 108
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`CCERTIFICAATE OF SEERVICE
`
`Carissa LL. Rodrigue (crodrigue@@mccarter.coom)
`
`
`Stepheen M. Hash
`(shash@vel
`
`
`VINSOON & ELKIINS, LLP
`
`
`2801 VVia Fortuna,, Suite 100
`
`
`Austinn, Texas 787746-7568
`
`aw.com)
`
`
`
`
`
`
`
`
`hereby certiify that on JJanuary 11, 22013, I caussed a true annd correct coopy of Answwer of
`I
`
`
`
`Dr. Redddy’s Laboratories, Ltdd. and Dr.
`
`Reddy’s LLaboratories,
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`Inc.; Rulee 7.1 Discl
`osure
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`Statemennt; and Certiffication Purssuant to L. CCiv. R. 11.2 tto be servedd via e-mail aand ECF upoon:
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`
`
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`John Flahherty (Jflaheerty@mccartter.com)
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`
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`
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`Jonathann Short (jshorrt@mccarterr.com)
`
`
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`MCCARRTER & ENGGLISH, LLPP
`
`
`Four Gatteway Centerr
`
`100 Mulbberry Street
`
`
`Newark, New Jersey 07102
`
`
`
`Einar Stoole (estole@cov.com)
`
`
`
`COVINGGTON & BUURLING LLLP
`
`
`1200 Pennnsylvania AAvenue
`
`
`Washinggton, DC 200004-2401
`
`
`om)
`renk@fchs.cHenryy J. Renk (hr
`
`
`
`
`
`FITZPPATRICK CCELLA HARRPER &
`
`SCINTTO
`
`
`
`
`
`New YYork, NY 100104-3800
`
`1290 AAvenue of thhe Americass
`
`
`
`
`
`
`
`_____________ ______________________________________________
`
`
`
`
`
`
`Dmitry Sheelhoff (dshelhhoff@buddllarner.com)
`
`BUDD LARRNER, P.C.
`
`
`150 John F.. Kennedy PParkway
`Short Hills,
`
` New Jerseyy 07078
`
`
`Telephone ((973) 379-48800
`
`Dr. Reddy’ss Laboratoriies, Ltd. andd
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`
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`Attorneys foor Defendannts
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`Dr. Reddy’ss Laboratoriies, Inc.
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`00917971
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`12

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